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- Tasks: Lead regulatory strategies for innovative cancer diagnostics and collaborate with global teams.
- Company: Join Leica Biosystems, a leader in life sciences and diagnostics.
- Benefits: Comprehensive benefits, including health care and paid time off.
- Why this job: Make a real impact in cancer diagnostics and improve lives globally.
- Qualifications: Degree in science or engineering and extensive regulatory experience required.
- Other info: Dynamic team environment with opportunities for growth and innovation.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Biosystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. By harnessing Danaher’s system of continuous improvement, you help turn ideas into impact–innovating at the speed of life. At Leica Biosystems, we’re not just shaping the future of cancer diagnostics—we’re transforming lives. Our mission of Advancing Cancer Diagnostics, Improving Lives is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next‑generation, life‑changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business System which makes everything possible.
Senior Manager, Regulatory Affairs is responsible for developing and executing global regulatory strategies for high‑complexity diagnostics including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology space. This individual will lead cross‑functional regulatory initiatives, partnering with internal teams and external stakeholders to enable successful global commercialization of innovative technologies (including but not limited to IDEs; Performance Study Applications; IVDR TF in EU and 510k and PMA in USA). This position reports to the Senior Director, Regulatory Affairs and is part of the Global Regulatory Affairs Team located in Newcastle, UK and will be an on‑site role.
In This Role, You Will Have The Opportunity To
- Lead a team of Regulatory Affairs Professionals responsible for the development, authorship, and maintenance of global regulatory submissions (e.g., 510(k), PMA, EU IVDR Technical Files, STED) by defining requirements, standardizing processes, optimizing timelines, and adapting plans as needed.
- Collaborate globally and cross‑functionally (e.g., Clinical Affairs, Business Development, QA, R&D, Program Management) to define and execute regulatory strategies for Leica Biosystems technologies in cancer diagnostics, IVD, and Companion Diagnostics markets.
- Provide regulatory input for program planning, including resource needs, budgets, and timelines, while aligning with external partners on study designs and submission strategies.
- Engage and negotiate with global regulatory agencies to achieve product clearance/approval, while staying current on evolving regulations, guidance, and competitive landscapes.
- Share regulatory expertise across Leica and Danaher sites, contribute to cross‑functional initiatives, and apply Danaher Business System (DBS) tools to drive continuous improvement and measurable results.
The Essential Requirements Of The Job Include
- Bachelor’s, Master’s, or PhD in a scientific or engineering discipline.
- In‑depth working knowledge of FDA and EU regulatory requirements for IVD devices.
- Extensive progressive experience supporting new product development and sustaining high‑complexity diagnostic products.
- Proven track record in developing and executing regulatory strategies and preparing global submissions for complex diagnostic products, including 510k and PMA submissions.
- Experience supporting clinical trials is a plus, along with strong understanding of regulatory requirements across international markets.
Travel, Motor Vehicle Record & Physical/Environment Requirements
- Ability to travel – list specifics 15% travel, overnight, within territory or locations.
It would be a plus if you also possess previous experience in:
- Applies deep regulatory expertise to the development and global commercialization of complex, high‑risk products, balancing short‑term problem solving with long‑term strategic outcomes and risk‑benefit analysis.
- Leads effectively in matrixed and cross‑cultural environments, driving timely decisions, issue resolution, and resource agility while setting high expectations and modeling accountability and integrity.
- Communicates complex and sensitive information clearly across diverse audiences; builds consensus, demonstrates strong writing and documentation skills, and uses sound judgment to influence and lead through change.
Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we’ll accelerate the real‑life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
Seniority level
Not Applicable
Employment type
Full‑time
Job function
Legal
Industries
Medical Device
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Senior Manager, Regulatory Affairs employer: Leica Biosystems
Contact Detail:
Leica Biosystems Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their mission and values, especially how they relate to cancer diagnostics. This will help you show your passion and fit for the role.
✨Tip Number 3
Practice your responses to common interview questions, but keep it natural. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your achievements in regulatory affairs.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can leave a lasting impression and show your enthusiasm for the position. And remember, apply through our website for the best chance!
We think you need these skills to ace Senior Manager, Regulatory Affairs
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Manager, Regulatory Affairs role. Highlight your experience with IVDs and regulatory submissions, as this will show us you understand what we're looking for.
Showcase Your Expertise: Don’t hold back on sharing your in-depth knowledge of FDA and EU regulations. We want to see how your expertise can contribute to our mission of advancing cancer diagnostics and improving lives.
Be Clear and Concise: When writing your application, keep it straightforward. Use clear language to communicate your achievements and experiences, as we appreciate strong writing skills that can convey complex information effectively.
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Leica Biosystems
✨Know Your Regulatory Stuff
Make sure you brush up on the latest FDA and EU regulatory requirements for IVD devices. Being able to discuss specific regulations and how they apply to high-complexity diagnostics will show that you're not just familiar with the basics, but that you’re ready to lead in this area.
✨Showcase Your Leadership Skills
As a Senior Manager, you'll be leading a team of Regulatory Affairs Professionals. Prepare examples of how you've successfully led cross-functional teams in the past, especially in high-pressure situations. Highlight your ability to drive decisions and resolve issues effectively.
✨Understand the Bigger Picture
Familiarise yourself with Leica Biosystems' mission and how it ties into cancer diagnostics. Be ready to discuss how your role can contribute to their goal of improving lives through innovative solutions. This shows that you’re aligned with their values and vision.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or negotiations with global agencies. Think through potential scenarios and how you would approach them, demonstrating your strategic thinking and problem-solving skills.
